Amplichek

Basic Information

• Brand Name: Amplichek
• Primary DI: 00847661005940
• Version / Model: 12000203
• Catalog Number: 12000203
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 051624070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 6
• Public Version Date: 2021-07-29
• Public Version Status: Update
• Public Device Record Key: a139537a-ad87-4a22-81d2-8863f5bc74a9

Device Description

Amplichek II Level 2 (A nucleic acid control.)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMN	Assayed external control material for microbiology nucleic acid amplification (NAT) assays	Microbiology	866.3920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50901	Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring vancomycin resistance, in vancomycin-resistant Enterococcus (VRE) bacteria isolated by culture from a clinical specimen.	No	Active
50838	Clostridium difficile nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.	No	Active
51669	MRSA nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847661005940	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN150058	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius